DRUG DESCRIPTION

Beclomethasone dipropionate is a white to creamy white, odorless powder a molecular weight of 521.25 (double strength 521.05). It is very slightly soluble in water, very soluble in chloroform, and freely soluble in acetone and in alcohol.

Beclomethasone dipropionate nasal inhalers are pressurized metered-dose aerosol units containing a microcrystalline suspension of beclomethasone dipropionate-trichloromonofluoromethane clathrate in a mixture of propellants (trichloromonofluoromethane and dichlorodifluoromethane) with oleic acid. Each canister contains beclomethasone dipropionate-trichloromonofluoromethane clathrate having a molecular proportion of beclomethasone dipropionate to trichloromonofluoromethane between 3:1 and 3:2.

Beconase (beclomethasone nasal) Nasal Inhaler: Each actuation delivers from the compact actuator a quantity of clathrate equivalent to 42 mcg of beclomethasone dipropionate. The contents of one 6.7 g-nasal inhaler canister provide at least 80 metered doses and the contents of one 16.8 g-nasal inhaler canister provide at least 200 metered doses.

Nasal Spray

Beclomethasone dipropionate, monohydrate is a white to creamy-white, odorless powder with a molecular weight of 539.06. It is very slightly soluble in water, very soluble in chloroform, and freely soluble in acetone and in alcohol.

This form is a metered-dose, manual pump spray unit containing a microcrystalline suspension of beclomethasone dipropionate, monohydrate equivalent to 0.042% w/w beclomethasone dipropionate calculated on the dried basis in an aqueous medium containing microcrystalline cellulose, carboxymethylcellulose sodium, dextrose, benzalkonium chloride, polysorbate 80, and 0.25% v/w phenylethyl alcohol; hydrochloric acid may be added to adjust pH. The pH is between 4.5 and 7.0.